Lives ruined as damage viewed as 'women's problems'
BBCMany lives have been ruined because officials failed to hear the concerns of women given drugs and procedures that caused them or their babies considerable harm, says a review.
More than 700 women and their families shared "harrowing" details about vaginal mesh, pregnancy test Primodos and epilepsy drug sodium valproate.
Too often worries and complaints were dismissed as "women's problems".
It said arrogant attitudes left women traumatised, intimidated and confused.
Review chair Baroness Julia Cumberlege said she was shocked by the "sheer scale" and "intensity of suffering".
She said: "I have conducted many reviews and inquiries over the years, but I have never encountered anything like this.
"Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself."
She said even now the exact numbers of women affected by the three issues was still not known and praised campaigners for fighting to raise the problems.
The cases span decades and are thought to affect hundreds of thousands of women and babies.
The review looked at three treatments:
- Primodos - a hormonal pregnancy test, withdrawn from the market in the 1978, which is thought to be associated with birth defects and miscarriages. The manufacturer, Schering, now part of Bayer, has always denied a link between the drug and deformities in babies.
- Sodium valproate - an epilepsy drug which, while effective for preventing seizures, can be harmful if taken during pregnancy, causing physical abnormalities to the baby in the womb as well as developmental delay and autism in children whose mothers took it.
- Pelvic mesh implants - used as a surgical option to treat prolapse and incontinence, some women say they have been left with internal damage and agonising chronic pain "like razors inside the body". In the last few years, the procedure has only been offered on the NHS under exceptional circumstances and high vigilance.
The review has set out the missed opportunities when something could or should have been done to prevent harm.
It said there was a culture of denial by a disjointed and defensive healthcare system that failed to listen to patients' concerns.
Hundreds of babies are being born each year to mothers "unaware" of the risks that sodium valproate can pose in pregnancy, said the review.
While some women have benefited from mesh implants, others have been left in agony.
The patients whose lives have been ruined
June Wray, 73 and from Newcastle, experienced chronic pain after having a vaginal mesh procedure in 2009.
"Sometimes the pain is so severe, I feel like I will pass out," she said.
"But when I told GPs and surgeons, they didn't believe me. They just looked at me like I was mad."
Kate Langley had a mesh fitted in 2012 for incontinence problems.
She said it had had a massive impact on her life, leading to more than 50 admissions to hospital when she was in acute pain.
"It was so hard to deal with. Years of going from one doctor to another."
She has now had four operations to remove the mesh.
Marie Lyon was prescribed Primodos when she was pregnant with her daughter, who was born with a shortened arm.
She began campaigning in 1978 and said the review was a "relief that there has finally been an acknowledgement" of the situation.
Mrs Lyon, chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests, said there was also "great sadness" that many of the original campaign members were not alive to see the result of the review.
What needs to happen now?
The review warned against pushing innovative treatments without enough long-term monitoring, and criticises manufacturers for being motivated by sales ahead of safety.
And it recommended:
- Appointing an independent patient safety commissioner to hold the health system to account
- Setting up discretionary payment schemes to meet the financial care costs of those already affected
- Creating a redress agency to help resolve future disputes
- Transparency of payments made to doctors by pharmaceutical and medical device companies
Kath Sansom, founder of Sling the Mesh campaign and a mother of two, said: "The report is hard hitting and recognises the total failure in patient safety, regulation and oversight in the UK.
"It also makes it very clear that our medical establishment is deeply entrenched in institutional denial and misogyny.
"While we welcome all of the recommendations, there is no glory in knowing thousands of women have been maimed by mesh since the late 1990s then ignored when they asked for help suffering debilitating, life altering and irreversible pain."
Epilepsy Action deputy chief executive Simon Wigglesworth said: "Nothing can undo the avoidable harm and distress that has been caused by the decades of government silence and inaction."
Health Minister Nadine Dorries said she was determined to make the changes needed to protect women in the future.
"Our health system must learn from those it has failed.
"We will now give this independent review the full and careful consideration it deserves before setting out our full response."